ARRHYTHMIA STUDIES


ARRHYTHMIA STUDIES: Contracted Research, Clinical Trials, Actively recruiting

RAFT-PERM AF
Funding: CIHR
Coordinating center: The Cardiovascular Research Method Centre (CRMC), University of Ottawa Heart Institute
Local PI: C Seifer
Co-investigators: A Khadem, A Tischenko, K Wolfe, C Khoo
Local contact:
Rebecca Medeiros
rmedeiros@sbgh.mb.ca
(204) 237-2380

Objective: Randomized double-blind controlled trial in patients with NYHA class II and III heart failure, in permanent AF with left ventricular systolic dysfunction, and prolonged QRS duration, to determine whether CRT when added to optimal medical therapy and ICD reduces all cause mortality or HF hospitalization

Inclusion criteria:

- NYHA Class II or III symptoms
- Permanent atrial fibrillation
- Optimal medical therapy for CHF for at least the past 3 months
- LVEF - Indication for an ICD for primary or secondary prevention of sudden cardiac death
- QRS duration >/= 130 ms when the QRS morphology is LBBB, or QRS duration >/= 150 ms when the QRS morphology is non-LBBB
Website: https://clinicaltrials.gov/ct2/show/NCT01994252

REFINE ICD
Funding: CIHR/Other
Coordinating center: University of Calgary (Libin Cardiovascular Institute)
Local PIs: C Seifer/ B Elbarouni
Co-investigators: A Khadem, A Tischenko, K Wolfe, C Khoo
Local contact:
Rebecca Medeiros
rmedeiros@sbgh.mb.ca
(204) 237-2380

Objective: To test whether an ICD will reduce mortality in patients with LVEF values of 0.36 to 0.50 plus abnormal T wave alternans (TWA) and Heart Rate Turbulence (HRT) measured 2 months to 5 years after MI.

Inclusion criteria:

- 18-80 years of age
- History of MI >/= 2 months and - Appropriate post-MI management including revascularization where indicated
- No contra-indication for transvenous ICD placement (e.g. mechanical TV, known vascular access problems, active sepsis, etc)
- LVEF 0.36 to 0.5 measured 2 months to 5 years after a confirmed MI, >/= 3 months after revascularization and - Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor/ARB, stain and anti-platelet)
- Sinus rhythm within the two weeks prior to the screening Holter
- Written informed consent
- Able and willing to complete a six minute walk and 24 hour Holter monitor

Additional Inclusion Criteria: (eligibility for randomization)

- Abnormal TWA and HRT on Holter
- In normal sinus rhythm for >/= 18 hours of the 24 hr screening Holter
>Website: http://refineicd.com/study.html

OPTISURE
Funding: St Jude Medical
Coordinating center: St Jude Medical
Local PI: C Seifer
Co-investigators: A Khadem, A Tischenko, K Wolfe, C Khoo
Local contact:
Rebecca Medeiros
rmedeiros@sbgh.mb.ca
(204) 237-2380

Objective: The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients that have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia, and who meet all the inclusion/exclusion criteria.

Inclusion criteria:

- Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
- Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Website: https://clinicaltrials.gov/ct2/show/NCT02235545

POST 4

Funding: CIHR and University of Calgary
Coordinating center: University of Calgary (Libin Cardiovascular Institute)
Local PI: C Seifer
Local contact:
Rebecca Medeiros
rmedeiros@sbgh.mb.ca
(204) 237-2380

Objective: To test the hypothesis that Midodrine prevents recurrences of vasovagal syncope in patients with moderate to severe vasovagal syncope.

Inclusion criteria:

- >/= 2 syncopal spells in the year preceding enrollment
- >/= -2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
- Age >/=18 years with informed consent

POST 5
Funding: CIHR and University of Calgary
Coordinating center: Libin Cardiovascular Institute
Local PI: C Seifer
Local contact:
Rebecca Medeiros
rmedeiros@sbgh.mb.ca
(204) 237-2380

Objective: To test the hypothesis that Metoprolol reduces the time to a first recurrence of syncope in patients ? 40 years old who have a high likelihood of recurrent vasovagal syncope.

Inclusion criteria:

- >/= 1 syncopal spells in the year preceding enrollment
- >/= -2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
- Age >/= 40 years old